drugset / Trial / NCT02015156

A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

NCT02015156

Phase 1 Completed 162 enrolled Pfizer
RandomizedParallel-groupTriple-blind

Summary

This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

Timeline

Start
2014-01
Primary completion
2014-02
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-05280014 Unknown 6 mg/kg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications

No indication recorded.